A catheter carrying a radially-expansible ultrasonic transducer is threaded into the circulatory system and then the transducer is actuated to provide ultrasonic energy in a ring-like zone surrounding a blood vessel. Desirably, the transducer is arranged to focus the ultrasonic energy into a narrow, ring-like focal zone having an extent, in the axial direction along the catheter, less than the axial extent of the transducer. The transducer desirably is expanded after threading so that during application of the ultrasonic energy, the transducer bears on the interior wall of a blood vessel through a balloon covering the transducer. The transducer may include one or more resilient spiral elements carrying a flexible piezoelectric material.
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4. An element comprising a piezoelectric element having a radiating surface in the form of a portion of a toroidal surface having a central axis, said portion of said toroidal surface facing outwardly away from said central axis, whereby said emitting element will focus emitted sonic energy in a generally circular band surrounding the element.
1. A sonic emitting element comprising a piezoelectric element having a radiating surface in the form of a surface of revolution of a generatrix about a central axis, said generatrix including a minimum point at a minimum distance from said central axis, a first portion sloping away from the axis in a first axial direction from said minimum point, and a second portion sloping away from said central axis in a second axial direction from said minimum point.
10. A method of treating tissue within the body of a subject comprising the steps of:
(a) threading a catheter into a circulatory system of the subject so that a emitting element carried on said catheter is positioned within a circulatory vessel with a central axis of the emitting element substantially aligned with an axis of the circulatory vessel, said emitting element having an axial length in a direction along said central axis; (b) actuating said emitting element to emit sonic energy in a pattern which is generally symmetrical about said central axis, said sonic energy being emitted so that the sonic waves from different portions of said emitting element intersect and mutually reinforce one another in a ring-like focal region surrounding said central axis, said focal region having an axial length less than the axial length of said emitting element.
2. An element as claimed in
3. An element as claimed in
5. An element as claimed in any of claims 1, 2, 3 and 4 wherein said piezoelectric element is formed from a polymeric piezoelectric material.
6. An element as claimed in
7. A catheter comprising an element as claimed
8. A catheter as claimed in
9. A catheter as claimed in
11. A method as claimed in
12. A method as claimed in
13. A method as claimed in
14. A method as claimed in
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The present application claims benefit of U.S. Provisional Patent Applications No. 60/173,533, filed Dec. 29, 1999 and 60/160,546, filed Oct. 20, 1999, the disclosure of which is hereby incorporated by reference herein.
The present invention relates to sonic emitting elements, to catheters incorporating the same and to methods of treating tissue in the body of a subject using such elements on catheters.
As described in International Publication WO 99/02096, the disclosure of which is hereby incorporated by reference herein, certain cardiac arrhythmias can be treated by ablating tissue in a ring around a pulmonary vein at the juncture between the pulmonary vein and the heart. As described in the '096 publication, such ablation can be performed by threading a catheter having a thermal ablation element at its distal tip into the heart so that the tip is lodged within the appropriate pulmonary vein. The catheter may bear a balloon which is inflated within the vein and which holds the catheter in place. The ablating element is then actuated so as to apply heat in a region surrounding the ablating element. In certain embodiments taught in the '096 publication, the ablating element includes a radio frequency ("RF") emitting antenna.
Other embodiments described in the '096 publication disclose the use of ultrasonic transducers. The ultrasonic transducer can be actuated to apply sonic energy through a fluid contained in the balloon, thereby heating the tissue surrounding the balloon. The preferred ultrasonic transducer illustrated in the '096 publication is a ceramic piezoelectric element in the form of an elongated hollow tube having two cylindrical electrodes on its covering inner and outer surfaces. The entire piezoelectric element is excited by an alternating voltage and emits generally cylindrical sonic pressure waves.
Such a cylindrical transducer can apply only limited levels of power within a given volume of tissue. The '096 publication suggests that a power level of 20 watts per centimeter of length along the vessel is adequate for ablation. While it is at least theoretically possible to heat tissues to a degree sufficient to cause ablation using relatively low power levels per unit of volume, such low-level heating prolongs the time required to heat the tissue. This, in turn, increases heat conduction from the heated tissues and increases the risk that adjacent tissue will suffer heat damage.
As also explained in the '096 publication, such a cylindrical transducer typically must have an axial length at least equal to the wavelength of the sound in the transducer material. Accordingly, such a transducer tends to ablate tissue along a significant length of the pulmonary vein. This is undesirable because the desired treatment only requires ablation of a short ring of tissue surrounding the pulmonary vein to interrupt an undesired electrical conduction path. To avoid this undesirable result, the '096 publication suggests masking the emissions from the ends of the cylindrical ultrasonic element. Such masking wastes the sonic power from the transducer, thus further aggravating the problem of providing adequate heating.
As a further alternative, the '096 publication shows an ultrasonic emitter in the form of a hollow concave disk. The '096 publication suggests that such an emitter can be physically rotated around the axis of a catheter so as to ablate a ring-like zone. This approach entails considerable practical difficulties inasmuch as entire rotatable assembly must be made to fit into a catheter which can be threaded through the circulatory system of the patient and into the pulmonary veins, typically a catheter having a diameter no more than a few mm.
Thus, despite all of the efforts devoted heretofore to development of procedures for ablating a circular region around a blood vessel, there are still substantial needs for further improvements.
The present invention addresses these needs. One aspect of the invention provides methods of ablating or otherwise treating tissues. A method according to this aspect of the invention desirably includes the step of threading a catheter into the circulatory system of the subject so that an emitting element carried on the catheter is positioned within a circulatory vessel with a central axis of the emitting element substantially aligned with an axis of the circulatory vessel. The emitting element is actuated to emit sonic energy in a pattern which is generally symmetrical about its central axis. The sonic energy is emitted so that the sonic waves from different portions of the emitting element intersect and mutually reinforce one another in a ring-like focal region surrounding the central axis, said focal region has an axial length less than the axial length of the emitting element. For example, sonic energy from different portions of the emitting element along the axial extent of emitting element may be directed at different angles to the central axis of the emitting element. Alternatively or additionally, sonic energy from different portions of the emitting element along the axial extent of emitting element may be emitted with different phases.
A further aspect of the present invention provides a sonic emitting element incorporating a piezoelectric element having a radiating surface substantially in the form of a surface of revolution generated by rotating a generatrix about a central axis. The term "generatrix" as used in this disclosure refers to a line or curve. The generatrix desirably includes a minimum point at a minimum distance from the central axis, and includes a first portion sloping away from the central axis in a first axial direction along the central axis from the minimum point. Desirably, the generatrix includes a second portion sloping away from the central axis in a second axial direction from the minimum point. The first and second portions of the generatrix desirably are curved and most preferably the first and second portions of the generatrix are segments of a circle. Thus, the radiating surface is in the form of an outwardly-facing concave portion of a toroidal surface.
The transducer may include one or more radially-expansible elements such as resilient spiral elements carrying a piezoelectric material such one or more layers of a polymeric piezoelectric film, together with electrodes used to actuate the film. Further aspects of the invention provide catheters incorporating sonic elements as discussed above.
As seen in
The piezoelectric element 10 most preferably is formed from a polymeric piezoelectric material such as polyvinylidene fluoride (PVDF) or a piezoelectric ceramic or composite material such as those commonly known as PZT-8 or PZT-4 and has at least two electrodes positioned so that piezoelectric material lies between the two electrodes. The particular transducer illustrated in
As will be appreciated with reference to
The emitting element discussed above desirably is mounted on an elongated catheter body 40 having a proximal end 42 and a distal end 44. The emitting element may be mounted remote from the proximal end and desirably adjacent the distal end of the catheter body. The catheter is provided with conductors 46 connected to the electrodes of the piezoelectric element. These conductors may be connected to a conventional high frequency generator for driving the piezoelectric element. The catheter may also include a balloon 50 similar to the balloon discussed in the '096 publication. Such a balloon may be filled with water or other ultrasonic-transmitting medium so as to couple the sonic emissions from the transducer into the surrounding tissues.
In a method according to a further aspect of the invention, the distal end 44 of the catheter is advanced through the circulatory system of the patient into a pulmonary vein V so that the balloon 50 and emitting element 10 are disposed in the vein adjacent to the juncture of the vein and the heart chamber H. Balloon 50 is inflated with water or other ultrasonic transmitting medium and bears against the inner wall of the vein. The piezoelectric element is actuated so as to heat the tissue in a ring-like region 36 surrounding the emitting element. Desirably, such heating is accomplished rapidly, within about 500 milliseconds. The ring-like element 36 is depicted in
In the method and apparatus discussed above, the piezoelectric element provides strong exitation, and can be readily formed into the shape desired as, for example, into a body of revolution about the central axis. The piezoelectric material thus greatly facilitates fabrication of transducers in the relatively small sizes, desirably less than about 1 cm and most desirably less than about 2 mm in diameter suitable for threading into the circulatory system of a human or other mammalian subject. The piezoelectric films can be wound or wrapped around the central support 32 to form the emitting element. As described in the aforementioned co-pending, commonly assigned patent application, the electrodes used on the piezoelectric films can be provided as printed conductive areas. For these and other reasons, the use of piezoelectric films is preferred. One particular PVDF piezoelectric material suitable for use in practice of the present invention is available from Measurement Specialties, Inc. of Norristown, Pa., United States of America.
Apparatus according to a further embodiment of the invention (
In a further embodiment, the transducer has a substantially cylindrical radiating surface divided into a plurality of bands 222, 223, 224 spaced axially along central axis 212. The piezoelectric material in each of these bands is provided with a separate set of electrodes. For example, the piezoelectric material in band 222 is associated with an inner electrode 201 and an outer electrode 203. A similar, separate set of inner and outer electrodes is provided for each of the other bands. The separate sets of electrodes are connected to the leads 240 extending through the catheter so that separate exitation signals may be applied to each band. For example, the outer electrode of each set may be a ground electrode, and all of the ground electrodes may be connected to a common lead, whereas separate "hot" connections extend to the opposing inner electrodes. In operation, the various bands of piezoelectric material are excited out of phase with one another, with the end bands 222 and 224 in phase-leading relation with the central band 223. Here again, the sonic waves from the various bands will constructively reinforce one another at a ring-like region surrounding axis 212.
A sonic emitter 300 (
Each of the elongated, striplike elements 302 and 304 is wound into a generally spiral configuration about a common central axis 326. As best seen in
A flexible balloon 336, referred to herein as the expansion balloon, is disposed inside the spiral elements 302 and 304. A further balloon 340, referred to herein as the cover balloon, is disposed outside of the spiral elements. The balloons and elements are mounted to an elongated catheter body 340 adjacent the distal end thereof, with the common central axis 326 of the spiral elements extending substantially coaxially with the axis of elongation of the catheter body. The catheter body has a passage 344 communicating with the interior of expansion balloon 336 and has a separate passage 346 communicating with the interior of cover balloon 340.
In a method according to a further embodiment of the invention, expansion balloon 336 is initially deflated, and elements 302 and 304 are in the contracted position illustrated in solide lines in
While the elements are in the expanded condition, they bear upon the interior wall W of the circulatory vessel through the cover balloon 340. A drive signal is applied to each piezoelectric film, causing it to emit sonic energy. The sonic energy from element 302 is directed radially outwardly, away from axis 326, and is also directed axially, in the first direction towards medial plane 334. The energy from element 304 is directed in a similar but opposite pattern, radially outwardly and in the second direction (to the left as seen in
In a further variant, an ultrasonic emitting assembly includes a plurality of spiral elements 602, 604, 606 (FIG. 6). These elements are generally similar to the spiral elements 302 and 304 discussed above with reference to
As shown in
The catheter illustrated in
Although the invention has been described above with reference to ablation of blood vessel walls, the same techniques can be used to ablate ring-like regions around other tubular anatomical structures. For example, catheters as describe above can be introduced into the urethra and the sonic element can be actuated to ablate a ring-like region within the prostate gland.
As these and other variations and combinations of the features discussed above can be utilized without departing from the present invention, the foregoing description of the preferred embodiments should be taken by way of illustration rather than by way of limitation of the invention.
Acker, David E., Novak, Alfred
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